Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT00537732
Status:
TERMINATED
Last Update Posted:
2014-02-25
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'recruitment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastro-oesophageal reflux disease'], 'conditions': ['Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '15245569', 'type': 'BACKGROUND', 'citation': 'Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. doi: 10.1111/j.1600-0773.2004.pto950102.x.'}]}, 'descriptionModule': {'briefSummary': 'Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory\n* Range of Age: 20-70\n* BMI: 20-30\n\nExclusion Criteria:\n\n* Patients who are allergic to proton-pump inhibitors or show incompatibility\n* Patients who have lactase deficiency\n* Patients who have severe chronic disease\n* Patients who participated in another study during the last three months\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT00537732', 'acronym': 'GERD', 'briefTitle': 'Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing', 'organization': {'class': 'OTHER', 'fullName': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}, 'officialTitle': 'Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing', 'orgStudyIdInfo': {'id': 'IKP-219'}, 'secondaryIdInfos': [{'id': '2006-004650-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': '3 tablets, only 20 mg omeprazole, genotype independent', 'interventionNames': ['Drug: omeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': '20 vs. 60 mg daily, genotype dependent', 'interventionNames': ['Drug: omeprazole']}], 'interventions': [{'name': 'omeprazole', 'type': 'DRUG', 'description': '20 mg daily', 'armGroupLabels': ['control group']}, {'name': 'omeprazole', 'type': 'DRUG', 'description': '20 vs. 60 mg daily, genotype dependent', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Matthias Schwab, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthias Schwab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Matthias Schwab', 'investigatorAffiliation': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}}}}